CLASS II ONGOING Drug recall · Reported 27 Mar 2024 · FDA Enforcement Report
Infumorph (Preservative-free Morphine Sulfate Sterile recalled
Hikma Pharmaceuticals USA is recalling Infumorph (Preservative-free Morphine Sulfate Sterile Solution) ampul, distributed nationwide in the US. The recall was initiated on 12 Mar 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0392-2024
- FDA event ID
- 94208
- Recalling firm
- Hikma Pharmaceuticals USA, Cherry Hill, NJ
- Brand
- Infumorph 200
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Mar 2024
- FDA classified
- 21 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 12 Mar 2024 | Recall initiated by company | |
| 21 Mar 2024 | Classified by FDA | +9 days |
| 27 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Infumorph (Preservative-free Morphine Sulfate Sterile Solution) ampul recalled?
Yes. Hikma Pharmaceuticals USA recalled Infumorph (Preservative-free Morphine Sulfate Sterile Solution) ampul on 12 Mar 2024. The recall is Class II and its status is Ongoing. Recall number D-0392-2024.
Why was it recalled?
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Which lots are affected?
Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Morphine recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 15 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |